Abstract: FR-OR58
Efficacy and Safety of Voclosporin Over 3 Years in Patients With Severe Lupus Nephritis
Session Information
- Glomerular Diseases: From Bench to Bedside
November 04, 2022 | Location: W414, Orange County Convention Center‚ West Building
Abstract Time: 05:33 PM - 05:42 PM
Category: Glomerular Diseases
- 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials
Authors
- Menn-Josephy, Hanni, Boston University School of Medicine, Boston, Massachusetts, United States
- Truman, Matt, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
- Palmen, Mary, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
- Leher, Henry, Aurinia Pharmaceuticals Inc, Victoria, British Columbia, Canada
Background
The AURORA 1 study demonstrated that addition of voclosporin, a novel calcineurin inhibitor, to mycophenolate mofetil (MMF) and low-dose steroids significantly increased rates of complete renal response (CRR) at 52 weeks in patients with lupus nephritis, with efficacy maintained for an additional 24 months in those who continued treatment in the AURORA 2 study. Here we report on a post hoc analysis evaluating voclosporin use in patients with severe lupus nephritis using pooled data from the AURORA 1 and AURORA 2 studies.
Methods
Patients who completed AURORA 1 were eligible to enter AURORA 2 to continue the same blinded therapy of voclosporin or placebo; all patients received MMF and low-dose steroids. In this post hoc analysis, the definition of severe lupus nephritis included patients with Class III or IV (± Class V) disease with active lesions and urine protein creatinine ratio (UPCR) ≥3 mg/mg at AURORA 1 baseline. CRR was defined as UPCR ≤0.5 mg/mg with stable renal function, use of low-dose steroids, and no use of rescue medication and was assessed over the three-year treatment period of AURORA 1 and AURORA 2.
Results
Of the 116 patients in the voclosporin arm and 100 patients in the control arm who continued treatment in AURORA 2, 47 and 37 patients in each arm, respectively, had severe disease. Mean (SD) UPCR at pre-treatment AURORA 1 baseline was 6.02 (2.29) mg/mg in the voclosporin arm and 6.08 (2.46) mg/mg in the control arm. Rates of CRR in the voclosporin and control arms were 46.8% and 21.6%, respectively, at one year (OR 4.41, 95% CI 1.47, 13.26; p=0.008), 57.4% and 35.1% at two years (OR 3.08, 95% CI 1.17, 8.10; p=0.022), and 53.2% and 35.1% at three years (OR 2.92, 95% CI 1.07, 7.94; p=0.036). The rates of serious adverse events were similar in the voclosporin (21.3%) and control (27.0%) arms, with one death occurring in a control-treated patient.
Conclusion
In patients with severe lupus nephritis, adding voclosporin to MMF and low-dose steroids results in significantly higher CRR rates and a similar safety profile to that of control. This is clinically meaningful given that patients with severe disease are at higher risk of worse long-term outcomes and development of end stage kidney disease.
Funding
- Commercial Support –